Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCT00759330 | Registry Identifier | ClinicalTrials.gov |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this trial is to evaluate the analgesic efficacy and safety of flurbiprofen tape for chronic low back pain (lasting greater than 3 months).
This study is a multi-center, randomized, double-blind, placebo-controlled study in patients with daily low back pain below the 12th thoracic vertebra of greater than 3 months duration. Patients also had an average daily pain score of 4 or greater on an 11-point categorical pain scale for the last 3 days of the baseline phase. The study began with a 14-day washout period of previously used pain medications. At the end of the 14-day baseline phase, patients were randomized to 1 of 4 treatments: Flurbiprofen tape applied once daily for 12 hours, Flurbiprofen tape applied once daily for 24 hours, placebo tape applied once daily for 12 hours, or placebo tape applied once daily for 24 hours. During the 7-day treatment phase, patients applied 2 treatment tapes once daily for 7 days. The tapes remained on for 12 or 24 hours of continuous treatment, depending on the treatment to which they were randomized. Patients were provided with rescue medication. After 7 days of tape treatment, patients returned to the clinic for a study exit visit.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Tape (Arm 1) | Placebo Comparator | Placebo tape remained on for 12 hours of continuous treatment per day. |
|
| Flurbiprofen Tape (Arm 2) | Experimental | Flurbiprofen tape remained on for 12 hours of continuous treatment per day. |
|
| Placebo Tape (Arm 3) | Placebo Comparator | Placebo tape remained on for 24 hours of continuous treatment per day. |
|
| Flurbiprofen Tape (Arm 4) | Experimental | Flurbiprofen tape remained on for 24 hours of continuous treatment per day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo Tape (Arm 1) | Drug | Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Summed Pain Intensity Difference (SPID+) | The primary efficacy endpoint was the cumulative summed pain intensity difference (SPID+) at Days 4 and 7 of the tape treatment phase as computed from the daily categorical pain scale score reported on the patient's daily diary during the tape treatment phase; pain was rated on an 11-point scale, where: 0 = no pain, 10 = worst pain imaginable. Summed pain intensity difference is the sum of the pain intensity differences (PID). PID at each post-baseline evaluation was computed as the average baseline categorical pain scale score minus the post-baseline categorical pain scale score from the daily dairy. For patients with multiple pain scores reported on a given post-baseline study day, the PID scores were averaged to compute one daily PID score for each patient. | Days 4 and 7 of tape treatment phase |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity Difference (PID+) | +PID = pre-treatment value at baseline - post-treatment value at day of evaluation, where: pre-treatment value at baseline = average daily pain over the last 3 days of the baseline phase (ie, average of daily averages of the categorical pain scale scores for the last 3 days of the baseline phase). Pain was rated on an 11-point scale, where: 0 = no pain, 10 = worst pain imaginable. A positive PID indicates a reduction in pain. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| James Song | Teikoku Pharma USA, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Redpoint Research | Phoenix | Arizona | 85029 | United States | ||
| Diablo Clinical Research, Inc. |
Prior to randomization into the Tape Treatment Phase, participants began a 14-day washout period of previously used pain medications. Participants were then randomized to 1 of 4 treatments. After 7 days of treatment, patients returned to the clinic for a study exit visit. Participants were provided with rescue medication throughout the study.
The study was conducted at 10 clinical sites in the US from September 2007 to July 2008. Patients with chronic LBP below the 12th thoracic vertebra of greater than 3 months duration and with an average daily pain score of 4 or greater on an 11-point categorical pain scale for the last 3 days of the baseline phase were eligible to participate.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Tape, Daily for 12 Hours | Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day. |
| FG001 | Flurbiprofen Tape, Daily for 12 Hours |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Flurbiprofen Tape (Arm 2) | Drug | Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg. |
|
| Placebo Tape (Arm 3) | Drug | Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. |
|
| Flurbiprofen Tape (Arm 4) | Drug | Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg. |
|
| Days 1 through 7 of tape treatment phase |
| Average Daily Categorical Pain Scale Scores | Patients rated their lower back pain, caused by normal activity and movement, on an 11-point categorical pain scale, where: 0 = no pain, and 10 = worst pain imaginable. Patients rated their lower back pain every 12 hours, at any time they took medication including rescue medication for any type of pain, and if they applied or removed their treatment tapes at a time other than the scheduled time. Data are reported as the daily average categorical pain scale score by treatment group. | Days 1 through 7 of tape treatment phase |
| Percent Change From Baseline in Total Functional Rating Index (FRI) | Patients completed the FRI, a 10-item back pain-specific measure of function questionnaire describing the condition at the time the questionnaire was completed; each item (pain intensity, sleeping, personal care, travel, etc.) was rated on a 5-point scale, where 0 = best outcome, 4 = worst outcome. FRI was reported as the percent change from baseline at Day 7 of the tape treatment phase, where: Total FRI score = sum of the 10 questions. The total FRI score ranged from 0 (best outcome) to 40 (worst outcome). Percent change = ([baseline - Day 7]/baseline)*100. A positive percent change indicates a favorable treatment effect. | baseline to Day 7 of tape treatment phase |
| Change From Baseline in Total Tender Point Examination Score | At baseline and Day 7 of the tape treatment phase, patients had an assessment of tenderness bilaterally at the sacroiliac joint, greater trochanter of the hip, gluteus medius and minimus, and paraspinal muscles at L3-L4, L4-L5, and L5-S1. The investigator or research nurse pressed 12 specific areas of the body (6 locations, left and right sides), and patients were asked to rate the intensity of their pain at those 12 areas using an 11-point scale, where: 0 = no pain, 10 = the worst pain the patient has ever experienced. The total tender point examination score ranged from 0 (best outcome) to 120 (worst outcome). Change from baseline = baseline - Day 7. A positive change indicates a favorable treatment effect. | Baseline to Day 7 of tape treatment phase |
| Patient Global Impression of Change (PGIC) | At Day 7, patients provided their PGIC with regard to lower back pain response to treatment, using a 7-point scale, where: 1 = very much improved, 7 = very much worse. | Day 7 |
| Acetaminophen Used During the Tape Treatment Phase | The percentage of patients who used rescue medication during the tape treatment phase. | Day 1 through Day 7 of the tape treatment phase |
| Acetaminophen Used During the Tape Treatment Phase | The total amount (mg) of rescue medication used during the tape treatment phase. | Day 1 through Day 7 of the tape treatment phase |
| Percentage of Patients Who Discontinued | The percentage of patients who discontinued the study during the tape treatment phase due to lack of efficacy. | Days 1 through Day 7 of tape treatment phase |
| Patient Assessment of Wearability of Therapy | At Day 7, patients assessed the wearability of their treatment tape (ease of application, stays in place, comfortable to wear) using a 4-point scale, where: 1 = Excellent, 4 = Poor. | Day 7 |
| Walnut Creek |
| California |
| 94598 |
| United States |
| University Foundation for Education and Research, Inc. | Tampa | Florida | 33606 | United States |
| Palm Beach Research Center | West Palm Beach | Florida | 33409 | United States |
| Internal Medicine Associates of Cordova | Cordova | Tennessee | 38018 | United States |
| Sarah Cannon Research Institute | Memphis | Tennessee | 38119 | United States |
| Senior Adults Specialty Research | Austin | Texas | 78757 | United States |
| Charolettesville Medical Research | Charlottesville | Virginia | 22911 | United States |
| Rainier Clinical Research Center, Inc. | Renton | Washington | 98057 | United States |
| Aurora Advanced Healthcare, Inc. | Milwaukee | Wisconsin | 53209 | United States |
Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg. |
| FG002 | Placebo Tape, Daily for 24 Hours | Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. |
| FG003 | Flurbiprofen Tape, Daily for 24 Hours | Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. Each tape included 31.5 mg flurbiprofen for a total daily dose of 63 mg. |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Tape, Daily for 12 Hours | Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day. |
| BG001 | Flurbiprofen Tape, Daily for 12 Hours | Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg. |
| BG002 | Placebo Tape, Daily for 24 Hours | Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. |
| BG003 | Flurbiprofen Tape, Daily for 24 Hours | Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cumulative Summed Pain Intensity Difference (SPID+) | The primary efficacy endpoint was the cumulative summed pain intensity difference (SPID+) at Days 4 and 7 of the tape treatment phase as computed from the daily categorical pain scale score reported on the patient's daily diary during the tape treatment phase; pain was rated on an 11-point scale, where: 0 = no pain, 10 = worst pain imaginable. Summed pain intensity difference is the sum of the pain intensity differences (PID). PID at each post-baseline evaluation was computed as the average baseline categorical pain scale score minus the post-baseline categorical pain scale score from the daily dairy. For patients with multiple pain scores reported on a given post-baseline study day, the PID scores were averaged to compute one daily PID score for each patient. | Reported data are based on Intent-to-Treat patient population. | Posted | Least Squares Mean | Standard Error | units on a scale | Days 4 and 7 of tape treatment phase |
|
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Pain Intensity Difference (PID+) | +PID = pre-treatment value at baseline - post-treatment value at day of evaluation, where: pre-treatment value at baseline = average daily pain over the last 3 days of the baseline phase (ie, average of daily averages of the categorical pain scale scores for the last 3 days of the baseline phase). Pain was rated on an 11-point scale, where: 0 = no pain, 10 = worst pain imaginable. A positive PID indicates a reduction in pain. | Reported data are based on Intent-to-Treat patient population. | Posted | Least Squares Mean | Standard Error | units on a scale | Days 1 through 7 of tape treatment phase |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Average Daily Categorical Pain Scale Scores | Patients rated their lower back pain, caused by normal activity and movement, on an 11-point categorical pain scale, where: 0 = no pain, and 10 = worst pain imaginable. Patients rated their lower back pain every 12 hours, at any time they took medication including rescue medication for any type of pain, and if they applied or removed their treatment tapes at a time other than the scheduled time. Data are reported as the daily average categorical pain scale score by treatment group. | Reported data are based on Intent-to-Treat patient population. | Posted | Mean | Standard Deviation | units on a scale | Days 1 through 7 of tape treatment phase |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Total Functional Rating Index (FRI) | Patients completed the FRI, a 10-item back pain-specific measure of function questionnaire describing the condition at the time the questionnaire was completed; each item (pain intensity, sleeping, personal care, travel, etc.) was rated on a 5-point scale, where 0 = best outcome, 4 = worst outcome. FRI was reported as the percent change from baseline at Day 7 of the tape treatment phase, where: Total FRI score = sum of the 10 questions. The total FRI score ranged from 0 (best outcome) to 40 (worst outcome). Percent change = ([baseline - Day 7]/baseline)*100. A positive percent change indicates a favorable treatment effect. | Reported data are based on Intent-to-Treat patient population. Discrepancy in the number of participants analyzed for this outcome measure is due to discontinuations: 1 participant in the placebo tape12 hour group and 2 participants in the flurbiprofen tape groups (1 in the 12 hour group and 1 in the 24 hour group). | Posted | Least Squares Mean | Standard Error | percent change from baseline | baseline to Day 7 of tape treatment phase |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Total Tender Point Examination Score | At baseline and Day 7 of the tape treatment phase, patients had an assessment of tenderness bilaterally at the sacroiliac joint, greater trochanter of the hip, gluteus medius and minimus, and paraspinal muscles at L3-L4, L4-L5, and L5-S1. The investigator or research nurse pressed 12 specific areas of the body (6 locations, left and right sides), and patients were asked to rate the intensity of their pain at those 12 areas using an 11-point scale, where: 0 = no pain, 10 = the worst pain the patient has ever experienced. The total tender point examination score ranged from 0 (best outcome) to 120 (worst outcome). Change from baseline = baseline - Day 7. A positive change indicates a favorable treatment effect. | Reported data are based on Intent-to-Treat patient population. Discrepancy in the number of participants analyzed for this outcome measure is due to discontinuations: 1 participant in the placebo tape12 hour group and 2 participants in the flurbiprofen tape groups (1 in the 12 hour group and 1 in the 24 hour group). | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to Day 7 of tape treatment phase |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Patient Global Impression of Change (PGIC) | At Day 7, patients provided their PGIC with regard to lower back pain response to treatment, using a 7-point scale, where: 1 = very much improved, 7 = very much worse. | Reported data are based on Intent-to-Treat patient population. Discrepancy in the number of participants analyzed for this outcome measure is due to discontinuations: 1 participant in the placebo tape12 hour group and 2 participants in the flurbiprofen tape groups (1 in the 12 hour group and 1 in the 24 hour group). | Posted | Number | participants | Day 7 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Acetaminophen Used During the Tape Treatment Phase | The percentage of patients who used rescue medication during the tape treatment phase. | Reported data are based on Intent-to-Treat patient population. | Posted | Number | percentage of patients | Day 1 through Day 7 of the tape treatment phase |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Acetaminophen Used During the Tape Treatment Phase | The total amount (mg) of rescue medication used during the tape treatment phase. | Reported data are based on Intent-to-Treat patient population. | Posted | Least Squares Mean | Standard Error | mg | Day 1 through Day 7 of the tape treatment phase |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients Who Discontinued | The percentage of patients who discontinued the study during the tape treatment phase due to lack of efficacy. | Reported data are based on Intent-to-Treat patient population. | Posted | Number | percentage of patients who discontinued | Days 1 through Day 7 of tape treatment phase |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Patient Assessment of Wearability of Therapy | At Day 7, patients assessed the wearability of their treatment tape (ease of application, stays in place, comfortable to wear) using a 4-point scale, where: 1 = Excellent, 4 = Poor. | Reported data are based on Intent-to-Treat patient population. Discrepancy in the number of participants analyzed for this outcome measure is due to discontinuations: 1 participant in the placebo tape12 hour group and 2 participants in the flurbiprofen tape groups (1 in the 12 hour group and 1 in the 24 hour group). | Posted | Number | participants | Day 7 |
|
Adverse event data for the Tape Treatment phase (Days 1 - 7) are reported below.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo Tape, Daily for 12 Hours | Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day. | 0 | 20 | 9 | 20 | ||
| EG001 | Flurbiprofen Tape, Daily for 12 Hours | Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day. Each tape included 31.5 mg flurbiprofen for a total daily dose of 63 mg. | 0 | 42 | 11 | 42 | ||
| EG002 | Placebo Tape, Daily for 24 Hours | Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. | 0 | 22 | 12 | 22 | ||
| EG003 | Flurbiprofen Tape, Daily for 24 Hours | Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. Each tape included 31.5 mg flurbiprofen for a total daily dose of 63 mg. | 0 | 43 | 11 | 43 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stomach discomfort | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Application site erythema | General disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Application site irritation | General disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Application site paraesthesia | General disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Application site pruritus | General disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Application site rash | General disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Systematic Assessment |
|
An Institution Publication may be published provided that it does not disclose Confidential Information other than the study results from Institution's study data. The proposed Institution Publication shall be submitted to sponsor for review and comment at least 30 days prior to submitting it to a third party. If sponsor requests a delay in order to file patent applications, the Institution Publication may be delayed for submission to a third party for up to 120 days after sponsor request.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Teikoku Pharma USA, Inc. | 408-501-1821 |
| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| Male |
|
| SPID for Day 7 |
|
Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day.
| OG003 | Flurbiprofen Tape, Daily for 24 Hours | Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg. |
|
|
Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. |
| OG003 | Flurbiprofen Tape, Daily for 24 Hours | Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg. |
|
|
| OG002 | Placebo Tape, Daily for 24 Hours | Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. |
| OG003 | Flurbiprofen Tape, Daily for 24 Hours | Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg. |
|
|
Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
| OG002 | Placebo Tape, Daily for 24 Hours | Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. |
| OG003 | Flurbiprofen Tape, Daily for 24 Hours | Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg. |
|
|
| OG003 | Flurbiprofen Tape, Daily for 24 Hours | Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg. |
|
|
| Flurbiprofen Tape, Daily for 24 Hours |
Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. Each tape included 31.5 mg flurbiprofen for a total daily dose of 63 mg. |
|
|
| Flurbiprofen Tape, Daily for 24 Hours |
Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg. |
|
|
| Flurbiprofen Tape, Daily for 24 Hours |
Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg. |
|
|
| OG003 | Flurbiprofen Tape, Daily for 24 Hours | Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg. |
|
|